Principal CQV Consultant
16 hours ago
Cary
Principal CQV Consultant Seeking a CQV Subject Matter Expert with a dual mandate (1) Business Development / Pre?Sales to shape opportunities, lead solutioning, and win new CQV programs; and (2) Delivery Oversight to govern execution quality, ensure audit-ready outcomes, and drive client satisfaction across qualification and validation engagements. The ideal candidate blends technical depth in CQV (risk-based qualification, data integrity, computerized systems validation/assurance) with strong client-facing leadership, commercial acumen, and the ability to work seamlessly with onsite and remote/global teams. Responsibilities 1. Business Development & Pre?Sales Opportunity Creation & Client Engagement • Act as the primary CQV SME during pre-sales discussions with pharma/biotech clients, • Identify new qualification/validation opportunities across labs, manufacturing, QC, and QC IT landscapes, • Identify opportunities in facility, utilities, and equipment qualification projects including cleanrooms, HVAC, compressed gases, water systems (PW/WFI), autoclaves, incubators, and environmental monitoring systems, • Develop solutions and effort models for FAT/SAT support, commissioning, IQ/OQ/PQ, and performance verification of critical utilities. Lead requirement discovery sessions, customer workshops, and technical deep-dive meetings, • Build trusted advisor relationships with client stakeholders, • Engage early with prospects to qualify opportunities, discover needs, and shape CQV solution approaches (ASTM E2500, ISPE Baseline Guides, GAMP 5 2nd Ed., ICH Q9/Q10), • Develop end?to?end CQV solutions, including efforts, delivery models, assumptions, and risk mitigation approaches, • Lead RFP/RFI responses write technical sections, define scope, assumptions, and deliverable lists; develop estimates/BOEs, and contribute to pricing and SOWs. Prepare technical content for RFPs/RFIs, capability decks, proposals, and executive summaries, • Prepare and deliver client orals, capability briefings, demos, and case studies; tailor content to sponsor, QA, and IT stakeholders, • Create thought leadership content whitepapers, blogs, webinars, conference presentations on CQV best practices, data integrity, digital validation, Annex 1/Annex 11/21 CFR Part 11 readiness, etc, • Represent the company at conferences, industry forums, and customer roadshows Account Growth & Enablement · Build executive relationships; identify cross-sell and upsell in adjacent areas (e.g., digital validation, audit trail review, data integrity remediation, lab system migrations). · Maintain a credible POV on CSA, Annex 11 alignment, AI/GenAI guardrails in GxP, and continuous monitoring of validated systems. 2. Delivery Oversight & Execution Support Project Oversight • Oversee qualification of analytical instruments, manufacturing equipment, and lab equipment. Provide SME oversight for ongoing CQV engagements (IQ/OQ/PQ, CSV, lab instrument qualification, analytical equipment qualification, facility & utilities qualification)., • Serve as engagement oversight lead{{:}} establish governance cadences, RAID management, and change control; ensure adherence to the client's QMS and project stage gates, • Design risk-based qualification strategies for equipment, utilities, and facilities (URS, QRA, DQ/IQ/OQ/PQ/PPQ), and CSV to CSA approaches for lab/manufacturing systems (21 CFR Part 11, Annex 11, Data Integrity/ALCOA+), • Advise and guide onsite/remote validation consultants on qualification strategy, deviations, test design, and documentation quality, • Troubleshoot technical issues and escalate risks proactively to both internal teams and clients, • Review and approve critical deliverables such as validation plans, test protocols, summary reports, traceability matrices, and risk assessments, • Ensure alignment with GxP, data integrity guidelines, FDA, EMA, WHO, and ICH expectations, • Provide technical QA on key deliverables (URS, QRA, protocols, summary reports, traceability matrices, validation plans/reports), • Work seamlessly with global teams across timelines and cultural contexts, • Establish standardized templates, best practices, and checklists across CQV projects, • Drive continuous improvement in delivery methodology, validation approaches, and documentation quality, • Direct blended teams (onsite/remote/offshore); set clear objectives, templates/standards, and working agreements, • Coach project leads/consultants; resolve technical blockers; ensure consistent application of risk-based practices and right-sizing documentation · Interface with client such as QA, CQV, MS&T, Manufacturing, IT/CSV, and business functions (Clinical, Quality, Supply). · Communicate status and risks effectively to executive sponsors; align priorities and success criteria. 3. Internal Enablement & Capability Building • Mentor validation engineers, team leads, and junior SMEs, • Support internal training initiatives on CQV trends, tools, and regulatory expectations, • Contribute to solution accelerators, reusable templates, and playbooks Qualifications • Bachelor's or master's in engineering, Life Sciences, Pharmacy, or related field, • 10-15 years in CQV/Validation within pharma/biotech (at least 5 years in client-facing leadership or program oversight). Demonstrated pre?sales experience is required, • Technical Depth (examples){{:}}, • CQV ASTM E2500, ISPE Baseline Guides, ICH Q9/Q10, risk-based qualification, FAT/SAT, DQ/IQ/OQ/PQ/PPQ, cleaning validation basics, utilities (WFI/PW/HVAC), and facility/equipment commissioning, • CSV/CSA 21 CFR Part 11, EU Annex 11, GAMP 5 (2nd Edition), Data Integrity (ALCOA+), risk-based testing, supplier assessment, periodic review, and continuous verification/monitoring, • Laboratory & Enterprise Systems (nice-to-have)QMS (e.g. Veeva Quality Suite), LIMS, CDS (e.g., OpenLab, Chromeleon, Empower), LES/ELN, MES, DMS etc., • Core Skills Solutioning and scoping; proposal writing; stakeholder management; delivery governance; risk management; excellent written and verbal communication; coaching and team leadership, • BD/Pre?Sales Win rate; qualified pipeline generated; proposal quality and cycle time; account growth; CSAT during orals/POCs, • Delivery Oversight On-time/on-budget delivery; audit/inspection outcomes; defect escape rates; change control efficacy; stakeholder satisfaction (NPS/CSAT), • Leadership & Impact Adoption of risk-based practices; reusables/accelerators created; mentor feedback; retention and engagement of team members, • Ability to travel (~20-40%, variable) for client workshops, site commissioning/qualification, and executive reviews. Comfortable leading hybrid delivery with remote/offshore teams